Recall Z-3209-2018 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Exactech, Inc.
Optetrak Logic CC Stem Extension, 22mm x 160mm The OPTETRAK Logic CC Total Knee System is indicated for use in skeletally mature individuals undergoing primary surgery for total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis and/or post-traumatic degenerative problems.
| Date | May 8, 2018 |
| Status | Open, Classified |
| Reason | Potentially have non-conforming internal threads. |
| Root cause | Under Investigation by firm |
| Action | The firm, Exactech, contacted the consignee on May 3, 2018 by telephone to notify the consignee to quarantine the device pending recall notice distribution. Exactech distributed an "URGENT MEDICAL DEVICE RECALL" notice dated May 7, 2018 to the consignee in possession of affected inventory by electronic mail on May 7, 2018. In order to comply with the notice, consignees have been instructed to: " Immediately cease distribution or use of this product. " Extend the information to their accounts that may have this product in their possession. " Identify and quarantine any of the subject devices i |
| Quantity | 1 |
| Distribution | US Distribution to Ohio only. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K150890 | Exactech Optetrak Logic CC Exactech, Inc., May 29, 2015 |